Tel: +44 (0)1954 252519
Download
Capability
Statement

Robustness, Ruggedness

Robustness, Ruggedness

Robustness is the capacity of a method to remain unaffected by small deliberate variations in method parameters. The robustness of a method is evaluated by varying method parameters such as percent organic, pH, ionic strength, temperature, etc., and determining the effect (if any) on the results of the method. As documented in the various published guidelines, robustness should be considered early in the development / validation of a method. In addition, if the results of a method or other measurements are susceptible to variations in method parameters, these parameters should be adequately controlled and a precautionary statement included in the method documentation. 
Ruggedness, according to Chemex, is the degree of reproducibility of the results obtained under a variety of conditions, expressed as %RSD. These conditions include different laboratories, analysts, instruments, reagents, days, etc. Ruggedness is a term falling out of favour.  Chemex addresses ruggedness as intermediate precision and reproducibility.